MODIFICATION TO MODULAR PLUS REVISION STEM

K030971 · Plus Orthopedics · LWJ · Apr 24, 2003 · Orthopedic

Device Facts

• Record ID: K030971
• Device Name: MODIFICATION TO MODULAR PLUS REVISION STEM
• Applicant: Plus Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.

Device Story

Modular PLUS Revision Stem is a cementless, two-part modular hip prosthesis; consists of distal anchorage module and proximal revision module connected by a multistage tapered coupling secured with a cylindrical screw. System allows 96 anatomical configurations using 24 distal and 6 proximal modules. Device is implanted by orthopedic surgeons in a clinical/surgical setting to replace damaged femoral bone structure. Provides structural support and anchorage in the distal femur for patients with significant bone loss or fracture. Benefits include restoration of hip joint function and stability through modular, patient-specific sizing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ti-6Al-4V alloy (ASTM F136). Surface: Grit blasted with corundum (4-6um roughness). Design: Two-part modular system with multistage tapered coupling and cylindrical screw. Cementless fixation.

Indications for Use

Indicated for patients with femoral fractures requiring cementless fixation where bone damage necessitates anchoring in the distal half of the femur.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Modular PLUS Revision stem (K994126)

Submission Summary (Full Text)

{0}------------------------------------------------

APR 2 4 2003

510(k) Summary

K03097/ page 14/

Date March 26, 2003

## Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name

Hip stem

### Classification name

Prosthesis, hip, semi-constrained, metal/polymer, uncemented LWJ per 21 CFR Sec. 888.3360

### Equivalent Device

The Modular PLUS® Revision Hip system with modifications have the same indications and fundamental scientific technology, and similar materials as the Modular PLUS Revision stem cleared on K994126.

### Device Description

The Modular PLUS Revision stem is a cementless two part modular system that consists of a distal anchorage module and proximal revision module, connected by a multistage tapered coupling, secured by a cylindrical screw.

A total of 96 different anatomically-matched stems can be combined for the left and right hips by using 24 distal and 6 proximal modules.

The Modular PLUS stem system is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um.

## Intended Use

The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.

## Summary of Technological Characteristics Compared to Predicate Device

The Modular PLUS Revision stem is similar to the Modular PLUS Revision stem cleared on K994126. Both stems have the same overall stem profile and are manufactured from similar titanium alloys (Ti6Al4V - new design & Ti6A17No - original design). The indications for use are the same for both stems. The only difference are the minor change in material, increase in diameter of coupling taper, anodization of coupling taper, and slight modification of connecting screw.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PLUS Orthopedics c/o Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, TX 78681

Re: K030971

Trade/Device Name: Modular PLUS® Revision Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: LWJ Dated: March 26, 2003 Received: March 28, 2003

Dear Mr. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Mr. J. D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Ko3697 510(k) number (if known):____

Modular PLUS Revision Stem Device Name:

Indications for Use:

# Modular PLUS Revision Stem Indications for Use

The Modular PLUS® Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.

ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of General, Neurological and Restorative Devices

510(k) Number

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use o

(Optional format 1-2-96)

Mark N Milkum

(Divisio Sign-Off) Division at General, Restorative and Neurological Devices

510(k) Number K030971